Short-term changes in cardiovascular risk determinants after temporarily stopping gender-affirming hormone therapy in older transgender women - a pilot study

Conditions

Transgender women using long-term gender-affirming hormone therapy

Brief summary

cardiovascular risk determinants: height, weight, body mass index (BMI), bioelectrical impedance analysis, blood pressure, heart rate, and laboratory measures including total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, and haematocrit

Detailed description

grip strength and varying determinants of general wellbeing, including Satisfaction with Life Scale, Subjective Happiness Scale, PROMIS Emotional Distress – Anxiety – Short Form 8a, PROMIS Emotional Distress – Depression – Short Form 8b, World Health Organization Quality of Life Assessment (WHO-QoL BREF), Pittsburgh sleep quality index, Body Image Scale, The hormonal symptoms questionnaire including an extra question about perceived skin changes and questions regarding an overall evaluation of perceived changes and experiences due to stopping/restarting GHT, General information including age, type and dose of estradiol therapy, surgical status (i.e., type of gonadectomy), cardiovascular morbidity, and medication, Lifestyle factors (i.e., smoking, alcohol consumption, physical activity by means of Baecke Activity Questionnaire) and laboratory measures including 17-beta estradiol (pmol/l), luteinizing hormone (E/l), follicle stimulating hormone (E/l), testosterone (nmol/l), Three extra blood samples per visit for storage in the established gender biobank

Related papers

No related papers found yet.

Interventions

DRUGEstradiol Sandoz pleister 50 µg/24 uur

DRUGpleisters voor transdermaal gebruik 4 mg/20 cm2

DRUGOestrogel 0

DRUG75 mg/dosis

DRUGtransdermale gel

DRUGSysten 75

DRUGpleisters voor transdermaal gebruik 75 microgram/24 uur

DRUGEstradiol Sandoz tablet 2 mg

DRUGfilmomhulde tabletten

DRUGProgynova 2 mg

DRUGomhulde tabletten

DRUGLenzetto 1

DRUG53 mg/dosis

DRUGspray voor transdermaal gebruik

DRUGoplossing

DRUGProgynova 1 mg

DRUGEstradiol Sandoz pleister 100 µg/24 uur

DRUGpleisters voor transdermaal gebruik 8 mg/40 cm2

DRUGSysten 50

DRUGpleisters voor transdermaal gebruik 50 microgram/24 uur

DRUGSysten 100

DRUGpleisters voor transdermaal gebruik 100 microgram/24 uur

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
cardiovascular risk determinants: height, weight, body mass index (BMI), bioelectrical impedance analysis, blood pressure, heart rate, and laboratory measures including total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, and haematocrit	—

Secondary

Measure	Time frame
grip strength and varying determinants of general wellbeing, including Satisfaction with Life Scale, Subjective Happiness Scale, PROMIS Emotional Distress – Anxiety – Short Form 8a, PROMIS Emotional Distress – Depression – Short Form 8b, World Health Organization Quality of Life Assessment (WHO-QoL BREF), Pittsburgh sleep quality index, Body Image Scale, The hormonal symptoms questionnaire including an extra question about perceived skin changes and questions regarding an overall evaluation of perceived changes and experiences due to stopping/restarting GHT, General information including age, type and dose of estradiol therapy, surgical status (i.e., type of gonadectomy), cardiovascular morbidity, and medication, Lifestyle factors (i.e., smoking, alcohol consumption, physical activity by means of Baecke Activity Questionnaire) and laboratory measures including 17-beta estradiol (pmol/l), luteinizing hormone (E/l), follicle stimulating hormone (E/l), testosterone (nmol/l), Three extra	—

Measure

Time frame

grip strength and varying determinants of general wellbeing, including Satisfaction with Life Scale, Subjective Happiness Scale, PROMIS Emotional Distress – Anxiety – Short Form 8a, PROMIS Emotional Distress – Depression – Short Form 8b, World Health Organization Quality of Life Assessment (WHO-QoL BREF), Pittsburgh sleep quality index, Body Image Scale, The hormonal symptoms questionnaire including an extra question about perceived skin changes and questions regarding an overall evaluation of perceived changes and experiences due to stopping/restarting GHT, General information including age, type and dose of estradiol therapy, surgical status (i.e., type of gonadectomy), cardiovascular morbidity, and medication, Lifestyle factors (i.e., smoking, alcohol consumption, physical activity by means of Baecke Activity Questionnaire) and laboratory measures including 17-beta estradiol (pmol/l), luteinizing hormone (E/l), follicle stimulating hormone (E/l), testosterone (nmol/l), Three extra

—

Countries

Netherlands

Outcome results

None listed